Drug Facts

Drug Facts

SPL v7

SPL

SPL Set ID dd967cfb-96b4-4cdc-82e2-a4838001c9e3

Route

ORAL

Published

Effective Date 2024-05-08

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Acetaminophen (160 mg) Chlorpheniramine (1 mg) Dextromethorphan (5 mg) Phenylephrine (2.5 mg)

Inactive Ingredients

Carboxymethylcellulose Sodium Cellulose, Microcrystalline Anhydrous Citric Acid D&c Red No. 33 Fd&c Blue No. 1 Fd&c Red No. 40 Glycerin Water Sodium Benzoate Sorbitol Sucrose Xanthan Gum

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2015-04-30

Description

Acetaminophen 160 mg Chlorpheniramine maleate 1 mg Dextromethorphan HBr 5 mg Phenylephrine HCl 2.5 mg

Purpose

Pain reliever/fever reducer Antihistamine Cough suppressant Nasal decongestant

Medication Information

Purpose

Pain reliever/fever reducer Antihistamine Cough suppressant Nasal decongestant

Description

Acetaminophen 160 mg Chlorpheniramine maleate 1 mg Dextromethorphan HBr 5 mg Phenylephrine HCl 2.5 mg

Uses

temporarily relieves the following cold/flu symptoms:
- minor aches and pains
- sore throat
- cough
- sneezing and runny nose
- headache
- nasal congestion
- stuffy nose
temporarily reduces fever

Purposes

Pain reliever/fever reducer

Antihistamine

Cough suppressant

Nasal decongestant

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes:

more than 5 doses (10 mL) in 24 hours, which is the maximum daily amount
with other drugs containing acetaminophen

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

skin reddening
blisters
rash

If a skin reaction occurs, stop use and seek medical help right away.

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Directions

this product does not contain directions or complete warnings for adult use
mL=milliliter
shake well before using
do not give more than 5 doses in any 24-hour peroid
measure only with dosing cup provided. Do not use any other dosing device.
keep dosing cup with product
if needed, repeat dose every 4 hours while symptoms last
find the right dose on chart below. If possible, use weight to dose, otherwise, use age.

Weight (lb)	Age (yr)	Dose (mL)
48-95	6-11	10 mL
36-47	4-5	do not use unless directed by a doctor
under 36	under 4	do not use

Do Not Use

to make a child sleepy
in a child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.
with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
if your child is allergic to acetaminophen or any of the inactive ingredients in this product

Package Label

WALGREENS Multi-Symptom Children's Cold and Flu

Other Information

store between 20-25ºC (68-77ºF). Do not refrigerate

Inactive Ingredients

anhydrous citric acid, carboxymethylcellulose sodium, D&C red #33, FD&C blue #1, FD&C red #40, flavor, glycerin, microcrystalline cellulose, purified water, sodium benzoate, sorbitol, sucrose, xanthan gum

Questions Or Comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

Compare to the active ingredients in Children's Tylenol® Plus Multi-Symptom Cold††

Multi-Symptom

Children's

Cold + Flu

ACETAMINOPHEN /

PAIN RELIEVER / FEVER REDUCER

CHLORPHENIRAMINE MALEATE /

ANTIHISTAMINE

DEXTROMETHORPHAN HBr /

COUGH SUPPRESSANT

PHENYLEPHRINE HCI /

NASAL DECONGESTANT

Relieves aches, fever, sore throat, sneezing, cough, runny & stuffy nose
Oral suspension

AGES 6 -11 YEARS

FL OZ (mL)

Grape flavor

DOSAGE CUP PROVIDED

††This product is not manufactured or distributed bt McNeil Consumer Healthcare, distributor of Children's Tylenol® Plus Multi-Symptom Cold.

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

DISTRIBUTED BY: WALGREEN CO

200 WILMOT RD., DEERFIELD, IL 60015

walgreens.com

When Using This Product

do not exceed recommended dose (see overdose warning)
excitability may occur, especially in children
marked drowsiness may occur
sedatives and tranquilizers may increase drowsiness

Stop Use and Ask A Doctor If

new symptoms occur
redness or swelling is present
pain, nasal congestion or cough gets worse or lasts more than 5 days
fever gets worse or lasts more than 3 days
nervousness, dizziness or sleeplessness occurs
cough comes back or occurs with rash or headache that lasts.These could be signs of a serious condition.

Keep Out of Reach of Children.

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical even if you do not notice any signs or symptoms.

Active Ingredients (in Each 5 Ml)

Acetaminophen 160 mg

Chlorpheniramine maleate 1 mg

Dextromethorphan HBr 5 mg

Phenylephrine HCl 2.5 mg

Ask A Doctor Before Use If the Child Has

liver disease
glaucoma
thyroid disease
diabetes
heart disease
high blood pressure
a breathing problem such as chronic bronchitis
persistent or chronic cough such as occurs with asthma
cough that occurs with too much phlegm (mucus)

Ask A Doctor Or Pharmacist Before Use If your Child Is Taking

sedatives or tranquilizers
the blood thinning drug warfarin

Structured Label Content

Uses

temporarily relieves the following cold/flu symptoms:
- minor aches and pains
- sore throat
- cough
- sneezing and runny nose
- headache
- nasal congestion
- stuffy nose
temporarily reduces fever

Purposes

Pain reliever/fever reducer

Antihistamine

Cough suppressant

Nasal decongestant

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes:

more than 5 doses (10 mL) in 24 hours, which is the maximum daily amount
with other drugs containing acetaminophen

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

skin reddening
blisters
rash

If a skin reaction occurs, stop use and seek medical help right away.

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Directions

this product does not contain directions or complete warnings for adult use
mL=milliliter
shake well before using
do not give more than 5 doses in any 24-hour peroid
measure only with dosing cup provided. Do not use any other dosing device.
keep dosing cup with product
if needed, repeat dose every 4 hours while symptoms last
find the right dose on chart below. If possible, use weight to dose, otherwise, use age.

Weight (lb)	Age (yr)	Dose (mL)
48-95	6-11	10 mL
36-47	4-5	do not use unless directed by a doctor
under 36	under 4	do not use

Do Not Use (Do not use)

to make a child sleepy
in a child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.
with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
if your child is allergic to acetaminophen or any of the inactive ingredients in this product

Package Label

WALGREENS Multi-Symptom Children's Cold and Flu

Other Information

store between 20-25ºC (68-77ºF). Do not refrigerate

Inactive Ingredients (Inactive ingredients)

Questions Or Comments? (Questions or comments?)

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

Compare to the active ingredients in Children's Tylenol® Plus Multi-Symptom Cold††

Multi-Symptom

Children's

Cold + Flu

ACETAMINOPHEN /

PAIN RELIEVER / FEVER REDUCER

CHLORPHENIRAMINE MALEATE /

ANTIHISTAMINE

DEXTROMETHORPHAN HBr /

COUGH SUPPRESSANT

PHENYLEPHRINE HCI /

NASAL DECONGESTANT

Relieves aches, fever, sore throat, sneezing, cough, runny & stuffy nose
Oral suspension

AGES 6 -11 YEARS

FL OZ (mL)

Grape flavor

DOSAGE CUP PROVIDED

††This product is not manufactured or distributed bt McNeil Consumer Healthcare, distributor of Children's Tylenol® Plus Multi-Symptom Cold.

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

DISTRIBUTED BY: WALGREEN CO

200 WILMOT RD., DEERFIELD, IL 60015

walgreens.com

When Using This Product (When using this product)

do not exceed recommended dose (see overdose warning)
excitability may occur, especially in children
marked drowsiness may occur
sedatives and tranquilizers may increase drowsiness

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

new symptoms occur
redness or swelling is present
pain, nasal congestion or cough gets worse or lasts more than 5 days
fever gets worse or lasts more than 3 days
nervousness, dizziness or sleeplessness occurs
cough comes back or occurs with rash or headache that lasts.These could be signs of a serious condition.

Keep Out of Reach of Children. (Keep out of reach of children.)

Active Ingredients (in Each 5 Ml) (Active ingredients (in each 5 mL))

Acetaminophen 160 mg

Chlorpheniramine maleate 1 mg

Dextromethorphan HBr 5 mg

Phenylephrine HCl 2.5 mg

Ask A Doctor Before Use If the Child Has (Ask a doctor before use if the child has)

liver disease
glaucoma
thyroid disease
diabetes
heart disease
high blood pressure
a breathing problem such as chronic bronchitis
persistent or chronic cough such as occurs with asthma
cough that occurs with too much phlegm (mucus)

Ask A Doctor Or Pharmacist Before Use If your Child Is Taking (Ask a doctor or pharmacist before use if your child is taking)

sedatives or tranquilizers
the blood thinning drug warfarin

Advanced Ingredient Data

[{"name": "ACETAMINOPHEN", "unii": "362O9ITL9D", "classCode": "ACTIB", "strengthNumerator": "160", "strengthDenominator": "5", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "CHLORPHENIRAMINE", "unii": "3U6IO1965U", "classCode": "ACTIB", "strengthNumerator": "1", "strengthDenominator": "5", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "DEXTROMETHORPHAN", "unii": "7355X3ROTS", "classCode": "ACTIB", "strengthNumerator": "5", "strengthDenominator": "5", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "PHENYLEPHRINE", "unii": "1WS297W6MV", "classCode": "ACTIB", "strengthNumerator": "2.5", "strengthDenominator": "5", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "CARBOXYMETHYLCELLULOSE SODIUM", "unii": "K679OBS311", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CELLULOSE, MICROCRYSTALLINE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ANHYDROUS CITRIC ACID", "unii": "XF417D3PSL", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "D&C RED NO. 33", "unii": "9DBA0SBB0L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C BLUE NO. 1", "unii": "H3R47K3TBD", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C RED NO. 40", "unii": "WZB9127XOA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM BENZOATE", "unii": "OJ245FE5EU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SUCROSE", "unii": "C151H8M554", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "XANTHAN GUM", "unii": "TTV12P4NEE", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "temporarily relieves the following cold/flu symptoms: minor aches and pains sore throat cough sneezing and runny nose headache nasal congestion stuffy nose temporarily reduces fever", "Purposes": "Pain reliever/fever reducer Antihistamine Cough suppressant Nasal decongestant", "Warnings": "Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes: more than 5 doses (10 mL) in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening blisters rash If a skin reaction occurs, stop use and seek medical help right away. Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.", "Directions": "this product does not contain directions or complete warnings for adult use mL=milliliter shake well before using do not give more than 5 doses in any 24-hour peroid measure only with dosing cup provided. Do not use any other dosing device. keep dosing cup with product if needed, repeat dose every 4 hours while symptoms last find the right dose on chart below. If possible, use weight to dose, otherwise, use age. Weight (lb) Age (yr) Dose (mL) 48-95 6-11 10 mL 36-47 4-5 do not use unless directed by a doctor under 36 under 4 do not use", "Do not use": "to make a child sleepy in a child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product. with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if your child is allergic to acetaminophen or any of the inactive ingredients in this product", "Package Label": "WALGREENS Multi-Symptom Children's Cold and Flu", "Other Information": "store between 20-25ºC (68-77ºF). Do not refrigerate", "Inactive ingredients": "anhydrous citric acid, carboxymethylcellulose sodium, D&C red #33, FD&C blue #1, FD&C red #40, flavor, glycerin, microcrystalline cellulose, purified water, sodium benzoate, sorbitol, sucrose, xanthan gum", "Questions or comments?": "Call 1-877-753-3935 Monday-Friday 9AM-5PM EST ", "Principal Display Panel": "Compare to the active ingredients in Children's Tylenol® Plus Multi-Symptom Cold†† Multi-Symptom Children's Cold + Flu ACETAMINOPHEN / PAIN RELIEVER / FEVER REDUCER CHLORPHENIRAMINE MALEATE / ANTIHISTAMINE DEXTROMETHORPHAN HBr / COUGH SUPPRESSANT PHENYLEPHRINE HCI / NASAL DECONGESTANT Relieves aches, fever, sore throat, sneezing, cough, runny & stuffy nose Oral suspension AGES 6 -11 YEARS FL OZ (mL) Grape flavor DOSAGE CUP PROVIDED ††This product is not manufactured or distributed bt McNeil Consumer Healthcare, distributor of Children's Tylenol® Plus Multi-Symptom Cold. TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING. KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION DISTRIBUTED BY: WALGREEN CO 200 WILMOT RD., DEERFIELD, IL 60015 walgreens.com", "When using this product": "do not exceed recommended dose ( see overdose warning ) excitability may occur, especially in children marked drowsiness may occur sedatives and tranquilizers may increase drowsiness", "Stop use and ask a doctor if": "new symptoms occur redness or swelling is present pain, nasal congestion or cough gets worse or lasts more than 5 days fever gets worse or lasts more than 3 days nervousness, dizziness or sleeplessness occurs cough comes back or occurs with rash or headache that lasts.These could be signs of a serious condition.", "Keep out of reach of children.": "Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical even if you do not notice any signs or symptoms.", "Active ingredients (in each 5 mL)": "Acetaminophen 160 mg Chlorpheniramine maleate 1 mg Dextromethorphan HBr 5 mg Phenylephrine HCl 2.5 mg", "Ask a doctor before use if the child has": "liver disease glaucoma thyroid disease diabetes heart disease high blood pressure a breathing problem such as chronic bronchitis persistent or chronic cough such as occurs with asthma cough that occurs with too much phlegm (mucus)", "Ask a doctor or pharmacist before use if your child is taking": "sedatives or tranquilizers the blood thinning drug warfarin"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:03:03.952876 · Updated: 2026-03-14T23:02:55.861635